Software-Guided heart valve implant aims to boost precision in aortic stenosis
NCT ID NCT07696182
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This clinical trial is testing a new heart valve replacement system called Encantor, which uses software to guide placement of the valve. The study includes 150 adults with severe aortic stenosis who are candidates for a minimally invasive procedure. Researchers will track how many patients survive without having a stroke one year after the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Encantor TAVI System (transcatheter aortic valve replacement device)
- What this could lead to
- If successful, this software-guided approach could make heart valve replacement safer and more precise for people with severe aortic stenosis.
- What could go wrong
- This is an early-stage study with only 150 participants, so results may not apply to everyone. Risks include complications from the procedure itself, such as stroke or death.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2038
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject identified as appropriate for transcatheter heart valve intervention therapy for the treatment of symptomatic, severe aortic stenosis. * Subject is of legal age for consent (18 years old). * Willing to return for required follow-up visits and assessments Exclusion Criteria: * Pregnant or nursing subjects. * Need for emergency surgery for any reason * Anatomic or comorbid conditions * Currently participating in an investigational drug or device study that has not reached the primary endpoint or may confound the results of this trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.